MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Catalog Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.Model #: unk.This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that a 12.6mm, implantable collamer lens was implanted into patient's right eye (os) and "small vault (70um) was observed.Reporter indicated cause of event was "sizing issue." a 13.2mm vicm5_13.2 was implanted into the patient's right.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: b5- "right eye" should be corrected to "left eye" in the initial mdr.B5- "a 13.2mm vicm5_13.2 was implanted into the patient's right." should be removed from the initial mdr.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9334502
• MDR Text Key: 167193908
• Report Number: 2023826-2019-02168
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Age: 28 YR